Benzinga | Jul 27, 2021 11:13AM EDT

Oragenics Enters Licensing Agreement With National Research Council Of Canada To Pursue Development Of SARS-CoV-2 Vaccines

* Agreement provides Oragenics with antigen expression cell line technology capable of producing spike proteins within six to eight weeks of gene sequence definition

* Technology includes the ability to engineer vaccine antigens against SARS-CoV-2 including Wuhan, South African (beta) and other emerging variants of concern

Oragenics, Inc. (NYSE:OGEN) today announced it has entered into a licensing agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue the rapid development of next-generation vaccines against the SARS-CoV-2 virus and its variants. The NRC technologies, in combination with the U.S. National Institutes of Health (NIH) elements found in the Company's Terra CoV-2 vaccine, provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC's Pandemic Response Challenge Program, will expedite the evaluation of SARS-CoV-2 antigen candidates in preclinical and clinical studies.

"Entering into this licensing agreement as well as a separate material transfer agreement with the NRC are expected to have a profound, positive impact on our company's strategic direction and we look forward to pursuing the development of next-generation vaccines against SARS-CoV-2," said Frederick W. Telling, Ph.D., Oragenics' Executive Chairman. "We believe the combination of our previously licensed NIH technology with the NRC's swift expression platform will accelerate design of new vaccine candidates that benefit from the hybrid NIH/NRC constructs. This license enables us to jumpstart IND-enabling animal studies with supplies of spike proteins to address the wild-type Wuhan virus as well as the Beta (B.1.351 or "South African") variant that is currently of global concern among public health professionals. Preclinical studies started in June through our collaboration with the NRC. We initiated an immunogenicity study in mice to evaluate several adjuvant candidates. This study will allow for down-selection of the adjuvant candidates, with the best being advanced into a hamster challenge study to assess inhibition of viral replication and an IND-enabling GLP toxicology study."

Dr. Telling added, "With respect to our potential future competitive positioning against currently available SARS-CoV-2 vaccines, we believe the licensed technologies will improve development speed, while the ability to rapidly engineer new vaccine antigens will permit us to quickly address new variants as they arise. In addition, our agreement with Biodextris for an intranasal adjuvant is expected to complement our intramuscular administration options and should position Oragenics with several antigen-adjuvant options in the event that SARS-CoV-2 become a seasonal flu-like disease, as many experts anticipate will be the case."